NL-OMON47674已完成不适用
Assessment of the WATCHMAN TM Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO) - ASAP-TOO
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. The subject is of legal age to participate in the study per the laws of their respective geography.
- •2. The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).
- •3. The subject has a calculated CHA2DS2-VASc score of 2 or greater.
- •4. The subject is deemed by two study physicians to be unsuitable for oral anticoagulation.
- •5. The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel* therapy following WATCHMAN Closure Device implant.
- •6. The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
- •7. The subject is able and willing to return for required follow-up visits and examinations.
排除标准
- •1. The subject is unable or unwilling to return for required follow-up visits and examinations.
- •2. The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
- •3. The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
- •4. The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization.
- •5. The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.
- •6. The subject has a history of atrial septal repair or has an ASD/PFO device.
- •7. The subject has an implanted mechanical valve prosthesis in any position.
- •8. The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
- •9. The subject has LVEF < 30%.
- •10. The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician*s discretion).
- •11. The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
- •12. The subject has a life expectancy of less than two years.
- •13. The subject has a known or suspected hypercoagulable state.
研究者
相似试验
终止
不适用
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral AnticoagulationStrokeNCT02928497Boston Scientific Corporation481
已完成
不适用
Validation of the NTX Wireless Patient Monitoring SystemDesaturationBradycardiaTachycardiaHypertensionHypotensionNCT00644644Vanderbilt University Medical Center1,303
已完成
不适用
The Use of Portable Wireless Monitor in Patient Vital Sign MonitoringVital SignsNCT06117111Tampere University Hospital30
已完成
不适用
Suitability of Unobtrusive Bed Monitoring and Wrist-worn Heart Rate Monitor for Patient MonitoringHemorrhageConsciousness, Loss ofSleepSeptic ShockArrhythmiaNCT03572751Tampere University Hospital36
已完成
不适用
Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseasesi) SARS-CoV-2 PCR positive COVID-19 patient ii) Heart failure iii) Sleep apnea syndrome iv) Asthma v) Chronic obstructive pulmonary disease vi) Intestinal pneumonia vii) Pulmonary mycobacterium avium complex disease viii) Pediatric inguinal hernia ix) Congenital cystic disease of lung x) Pediatric metastatic lung tumors xi) PneumoniaJPRN-UMIN000043546Innovative Clinical Research Center, Kanazawa University, Kanazawa, Japan20